Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder Cancer

NCT07095751 | Not Yet Recruiting

• 1 other identifier: CRE 2025.323
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm study investigating the safety, feasibility and diagnostic performance of AI-assisted Uro-Cam catheter assessment that will be performed at the Prince of Wales Hospital. All patients who are referred to the urology outpatient clinic for hematuria workup, and bladder cancer patients who require follow-up cystoscopy, will be screened for study eligibility. If eligible, patients will be recruited into the study with a proper informed consent. All recruited patients will undergo the AI-assisted Uro-Cam catheter assessment followed by a conventional flexible cystoscopy. The study will be conducted in accordance with the Declaration of Helsinki, and it will be registered in ClinicalTrials.gov. An AI-assisted Uro-Cam catheter assessment will be arranged for all recruited study subjects. After the AI-assisted Uro- Cam catheter assessment, a conventional flexible cystoscopy will be conducted in the same session. Biopsy will be taken from any suspicious lesion detected upon AI-assisted Uro-Cam catheter assessment or conventional flexible cystoscopy. After all the procedures, an End-of-study visit will be arranged 4-6 weeks later. The primary outcomes include 30-day complications, and the technical success rate of the AI-assisted Uro-Cam catheter assessment. 30-day complications will be assessed and grading according to the Clavien-Dindo classification. Technical success is defined by the completion of the whole Uro-Cam catheter assessment. The secondary outcomes include the AUC, sensitivity, specificity, positive predictive value, and negative predictive value in detecting histologically confirmed bladder cancer.

Conditions

Bladder Cancer

Keywords

AI; Uro-Cam; Bladder Cancer

Outcome Measures

Primary Outcomes (2)

• 30-day complications

  30-day complications will be assessed and grading according to the Clavien-Dindo classification.

  Thirty days after the allocated treatment

• Technical success rate

  Technical success is defined by the completion of the whole Uro-Cam catheter assessment.

  Immediately post-operative

Secondary Outcomes (1)

• Performance Evaluation

  Thirty days after the allocated treatment

Study Arms (1)

AI Uro-Cam

EXPERIMENTAL

All recruited patients will undergo the AI-assisted Uro-Cam catheter assessment followed by a conventional flexible cystoscopy in the same session. Biopsy will be taken from any suspicious lesion detected upon AI-assisted Uro-Cam catheter assessment or conventional flexible cystoscopy.

Device: AI Uro-Cam

Interventions

AI Uro-Cam DEVICE

As stated in AI Uro-Cam arm description

AI Uro-Cam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or above
• Fulfil any one of the following three criteria: (1) Macroscopic haematuria or persistent microscopic haematuria (microscopic haematuria in at least two urine tests), (2) Abnormal urine cytology results (Atypical cells in at least two urine cytology tests, OR Suspicious cells or malignant cells in at least one urine cytology test), (3)History of non-muscle-invasive bladder cancer with complete transurethral resection of bladder tumour performed

You may not qualify if:

• Presence of clinically significant cardiovascular disease (History of acute myocardial infarction, presence of uncontrolled angina within 3 months before screening, New York Heart Association Class III or IV congestive heart failure, presence of ventricular arrhythmias, or presence of second-degree or third-degree heart block)
• Any evidence of active urinary tract infection
• Presence of GOLD Stage III or IV chronic obstructive pulmonary disease
• ECOG performance status ≥ 2 (Ambulatory and capable of all self-care but unable to carry our any work activities)
• History of bleeding disorder or use of anti-coagulants
• Presence of other active malignancy
• Pregnancy

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Related Publications (16)

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MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Jeremy Yuen Chun TEOH, MBBS, FRCSEd

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeremy Yuen Chun TEOH, MBBS, FRCSEd

CONTACT

+852 35052625; jeremyteoh@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a pilot study investigating the safety, feasibility and diagnostic performance of AI-assisted Uro-Cam catheter assessment.

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: July 31, 2025
• Study Start: July 31, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)